1. Field of the Invention
The present invention relates generally to mechanical devices used in surgical procedures to obtain ligation or hemostasis, and more particularly, to low profile tools that can apply a pre-formed, spring loaded ligation clip used during surgery to clamp around a vessel or duct, such as the cystic duct, and thereby obtain ligation.
2. Description of the Prior Art
It will be appreciated by those skilled in the art that the use of ligation clips to control bleeding during surgical procedures is well known. As described, for example, in U.S. Pat. Nos. 4,976,722 and 4,979,950, prior art clips are generally formed of metal wire, usually a titanium alloy, having a “U-shaped” rectangular cross-section. Such prior art clips often include a grooved pattern machined into the inner or clamping surfaces of the clip, in an attempt to enhance the ability of the clip to remain in position after it is closed around the vessel. Application of the clip to the vessel is normally effected by means of a crushing action produced by a clip applier, such as disclosed in U.S. Pat. No. 5,030,226. Such crushing actions, of course, permanently deform the clips, making them difficult to remove or re-position.
Prior art surgical ligation clips have several inherent problems. For example, the force applied by the clip to the vessel can be variable and inconsistent from one clip to the next, because of the variation in crushing force applied to the clip by the user. Further, prior art clips have a tendency to slip off the end of the blood vessel stub (i.e., perpendicular to the axis of the vessel) to which it has been applied, because of the low coefficient of friction associated with the clip, and lack of adequate restraining force provided by the clip. Because of this, separation of the clip from the vessel to which it has been applied, after the wound has been closed, is not uncommon. A related problem found in the prior art is the fact that the ligating or restraining force offered by the crushed clip varies along the length of the clip, decreasing toward the open end. Thus, the section of the vessel near the open end of the clip can be inadequately ligated.
It is also common in the prior art to actually form and crush the clip only at the time of its application to the targeted blood vessel. It is often required that the vessels of 4 mm and larger diameter be ligated. Because most clips of the prior art have no spring action it is required that the inside clearance dimension of the clip, prior to crushing, be larger than the vessel. This does not lend itself to clip applier designs that will pass through small 5 mm trocars. The applier must be inserted through a trocar, placed through the patient's external tissues, and into the surgical field. Thus, prior art ligation clip appliers used in laparoscopic procedures typically consist of a 10 mm diameter clip applier that can fit only through a trocar having a 10 to 11 mm diameter entry port. Because one goal of laparoscopic surgery is to minimize the size of the entry wound, a surgical ligation clip and clip applier that can be used within a 5 mm or even a 2.5 mm diameter trocar port is highly desirable.
New minimally invasive surgical procedures and the need for less invasiveness for current procedures require the development of smaller and smaller devices. The harvesting of saphenous veins and certain cardiovascular procedures would benefit from reduced diameters trocars, below 3 mm diameter.
To address these problems a spring action surgical clip was designed, and is disclosed in U.S. Pat. No. 5,593,414, titled “Method of Applying a Surgical Ligation Clip,” the disclosure of which is incorporated herein by reference. One embodiment of the clip disclosed in the '414 patent is shown in FIGS. 1 and 2. Clip 50 has a vessel clamping arm 52, a vessel support member 54, and at least one tension coil 56 integrally joining the arm and support member. Clip 50 is pre-formed so that in its equilibrium state, it can be easily placed within the surgical field, including through an endoscopic trocar port with a diameter as little as 5 mm. After the clip is placed proximate the blood vessel or duct to be clamped, clamping arm 52 is moved from its equilibrium position to a position under higher tension, allowing positioning of the vessel between arm 52 and support member 54. When correct placement and positioning is achieved, arm 52 is released and, as the arm tends to move back towards its equilibrium position, it clamps the vessel between the arm's curved lower surface and the supporting upper surface of vessel support member 54.
To enhance the performance of the tension coil(s), vessel support member 54 includes first and second arms 58, 60, one of which terminates in a 180-degree bend section. Minimal cross-sectional area of the clip is achieved by substantially longitudinally aligning the vessel support member, the clamping arm, the 180-degree bend section 62, and the tension coil.
The clamping arm is pre-formed into an equilibrium that generally aligns with the horizontal plane of the support member. A second embodiment of the clip pre-loads the clamping arm into a pre-loaded equilibrium position where the free end of the arm rests against the upper surface of the support member.
There exists a relationship between the diameter of the trocar (hence the applier tube) and the maximum diameter of a vessel that can be ligated. Older crush clip technology limits the ratio of wound size to maximum diameter to be ligated to greater than 2. That is, to ligate a 5 mm vessel, a puncture wound of 10-12 mm is required. U.S. Pat. No. 5,593,414 teaches the method of using a spring clip that is inserted into the surgical field in the closed state, opened over a vessel, the diameter of which has been reduced, or pre-clamped, by the tool, and closed over the pre-clamped vessel. This method allows an entry wound to vessel diameter ratio of 1 or smaller. Thus, a 5 mm vessel can be ligated through a 5 mm trocar. This is substantially less invasive as compared to the older crush clip technology. For a trocar diameter of 2.5 mm, the clip can be scaled down to approximately half size on the wire diameter, coil height, and length, yet still supply an acceptable ligation force on a 2.5 mm vessel.
Unfortunately, several problems are encountered in applying the spring-action ligation clip of U.S. Pat. No. 5,593,414 to a vessel through a 5 mm or smaller trocar port. First, the nominal 5 mm cross-section of the clip that is inserted through the trocar places severe design restrictions on any applier mechanism. Second, care must be taken so that the elastic limit of the spring material is not exceeded when the clip is opened up so that it can be placed over the vessel diameter. For a titanium wire of diameter 0.75 mm, for example, lifting a distal end of a spring clip much above a few mm will exceed the elastic limit. Secondly, these spring clips are small and compact and owing to the preload, have a great deal of energy stored in the spring. As these clips are opened to place them over a vessel the stored energy increases substantially, in some cases more than doubling. This energy makes controlling the clip, to insure proper installation, difficult. Undesirable translation or rotation can result in misplacement or dropping of the clip inside the body.
Another approach which has been proposed to provide smaller diameter endoscopic clip application is that of U.S. Pat. No. 5,601,573 to Fogelberg et al. Fogelberg et al. still struggles with the complex manipulation required to advance the clip in a closed position and then open the clip prior to placement. Fogelberg et al. also has an overly complex multi-stage trigger arrangement for actuation of the jaws and the clip advancement mechanism. The present invention presents several improvements over Fogelberg et al. including the advancement of the clips in an open or semi-open position rather than a closed position.
The clip and clip applier disclosed in U.S. Pat. No. 6,350,269, titled “Ligation Clip and Clip Applier” and filed Mar. 1, 1999, the disclosure of which is incorporated herein by reference, represents a further improvement over the Fogelberg et al. device. The '269 patent discloses a clip having wire loops at one end thereof and a clip applier that utilizes the loop width to open and release the clip around a vessel.
There are several problems associated with the spring clip applicators of the prior art. For example, one problem is that the diverging surfaces of the jaws often obstruct the surgeon's view of the tissue to be ligated owing to the acute angle of the laparoscopic camera and the clip applier.
What is needed then is a clip applier without jaws, or with a single, fixed jaw so that the surgeon has a better view of the tissue to be ligated. Such a configuration also eliminates the severe pinching force on tissue that might be located near the axis or pivot point of an applicator having two jaws rotatable relative to one another. Additionally, the need to pre-clamp the tissue or vessel can be eliminated when a guide surface is provided that opens the clip to a sufficient height to be inserted over the vessel or tissue. The omission of the pre-clamping step eliminates any possible structural damage to the vessel or tissue that may otherwise be caused if the surgeon were to change his or her mind after clamping the vessel or tissue before applying the clip.
In the alternative, what is needed is a clip applier having jaws that remain in an open position until a clip is nearly at a release point along the jaws. Such a configuration allows the surgeon a last opportunity to carefully visualize the vessel to be ligated before clamping and attaching the ligation clip to the vessel.